1. Field of the Invention
The present disclosure relates to crystals of co-crystals and salts or polymorphic forms thereof having a co-crystal former and an active pharmaceutical ingredient. The present disclosure further relates to crystals of co-crystals and salts or polymorphic forms thereof having sorbitol and dexlansoprazole. The present disclosure still further relates to methods for making the co-crystals and salts or polymorphic forms thereof.
2. Description of the Related Art
Co-crystals and salts thereof are crystals of two or more components. Whether the crystal is in co-crystal form or salt form is determined by the location of the proton between an acid and a base. For acid-base complexes with similar pKa values, the extent of proton transfer in the solid state is not predictable and a continuum exists between the two extremes.
Co-crystals and their salts typically contain one or more active pharmaceutical ingredients (APIs). They typically contain one or more APIs and one or more formers that form crystals. The formers can take any form of matter, such as a solid, liquid, or gas, and can have neutral or ionic species.
Co-crystals and their salts can be manufactured by a variety of techniques, such as fast and slow evaporation of API/former solutions, sonication of supersaturated solutions, grinding, and melting, i.e., Kofler technique, and reaction crystallization. The selection of technique may vary depending on factors such as physical and chemical properties of the former(s), physical and chemical properties of the APIs, and manufacturing scale.
Co-crystals and their salts are useful forms for making, processing, or delivering active APIs. They are useful, for example, to optimize API stability, enhance API bioavailability, enhance manufacturing efficiency, modulate physical properties, and provide flexibility in regulatory compliance.
Teachings to co-crystals and their salts, their physicochemical properties, and methods for making are disclosed in Pharmaceutical Cocrystals and Their Physicochemical Properties by Schultheiss and Newman, Crystal Growth & Design 2009, vol. 9, no. 6, pp. 2950 to 2967, which is incorporated herein by reference in its entirety.
Dexlansoprazole is the pure enantiomer of lansoprazole. Dexlansoprazole and lansoprazole are APIs used for drug products that inhibit gastric acid secretion. They are useful in the treatment and maintenance of patients with erosive oesophagitis and non-erosive reflux disease, i.e. gastro-oesophageal reflux disease.
It would be desirable to have dexlansoprazole available in a co-crystal/salt form for patient administration. It would be desirable to have dexlansoprazole available in a co-crystal/salt form for inhibition of gastric acid secretion.